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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Aimmune’s Peanut Allergy Immunotherapy Brings Safety Concerns To US FDA Panel

Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.

Zydus Walks Away From US Dapagliflozin Appeal, ANDA Discontinued

In a blow to potential US generic competition, Zydus Cadila has withdrawn its appeal to an unfavorable federal ruling involving a US Farxiga (dapagliflozin) patent.

Nichi-Iko Set To Delist In March As Tamura Steps Down As CEO

After nearly two difficult years for Nichi-Iko Pharmaceutical, the firm has announced at it will be acquired by a private equity fund and delisted from the Toyko Stock Exchange in 2023 and its CEO will step down from his post.

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